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Teva says the brand product had annual sales of approximately $293 million in the United States for the twelve months that ended June 30, 2009, based on IMS sales data.
Teva is selling the drug in 60 and 120 milligram tablets. As the first company to file an ANDA (abbreviated new drug application) containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity in the US. The launch is in accordance with a compromise agreement between Barr, which Teva bought a year ago, and sanofi-aventis, under which Barr paid sanofi-aventis $30 million and will pay royalties on US sales of the drug.
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